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Serves as a "license to play" in the global pharmaceutical supply chain. iso 15378 key pointspdf free

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ISO 15378:2017 integrates ISO 9001 quality management principles with specific Good Manufacturing Practices (GMP) for primary packaging materials of medicinal products. Key requirements include risk management, traceability, controlled environments, and validated processes to ensure safety and compliance. Read a detailed guide at CertBetter . Requires detailed documentation of procedures

ISO 15378:2017 is the specific standard that integrates into a Quality Management System for primary packaging materials.

Requires detailed documentation of procedures, changes, deviations, and customer complaints. TÜV Rheinland Benefits of Implementation BS EN ISO 15378:2017